|- candidate number||5409|
|- NTR Number||NTR1695|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-mrt-2009|
|- Secondary IDs||Roessingh Research & Development NL25915.044.08|
|- Public Title||Evaluation of the Online Exercise Coach.|
|- Scientific Title||Evaluation of the Online Exercise Coach.|
|- ACRONYM||Online Exercise Coach|
|- hypothesis||Use of the Online Exercise Coach, an online tailored exercise program, will enhance compliance with a prescribed exercise program.|
|- Healt Condition(s) or Problem(s) studied||Chronic pain|
|- Inclusion criteria||1. Chronic low back pain;|
4. Age of 18 years or older.
|- Exclusion criteria||Insufficient control of the Dutch language.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-dec-2008|
|- planned closingdate||15-jun-2010|
|- Target number of participants||56|
|- Interventions||Subjects in the experimental group will receive six weeks of OEC follow-up treatment. Patients have access to their online tailored exercise programs by logging onto the website www.r-motion.nl. Patients’ former policlinic therapist will select a broad range of exercises from which the patient can choose from to create his own exercise programme. The exercises consist of mobilizing, muscle strengthening and conditional exercises. In addition patients have the opportunity to view the exercises on their computer by playing the video-files on the website. Also they are offered an email function on the website where they can contact their therapist in case they have questions about their exercises.
The control group comprises of a six week exercise follow-up program by means of once-only instruction by word of mouth at the end of the policlinic treatment at ‘Het Roessingh’. If patients experience problems during their six weeks of follow-up treatment they are instructed to call their therapist.
Patients in both the intervention and control group are asked to exercise for 30 minutes 3 times a week.|
|- Primary outcome||The primary objective is to investigate if the use of the Online Exercise Coach enhances compliance with the follow-up exercise program. Therefore the primary objective is: |
1. Are patients who used the OEC during their follow-up exercise treatment more compliant than patients who did not use the OEC?
|- Secondary outcome||Preferences:|
1. What are the preferences of chronic pain patients regarding exercise follow-up treatment?
A. Do chronic pain patients prefer the OEC or the traditional advice as exercise follow-up treatment?
B. Which attributes of OEC and traditional advice exercise follow-up treatment are considered as most important by chronic pain patients?
2. Do exercise follow-up treatment preferences change after patients completed their follow-up treatment?
3. How satisfied are patients on the factors of the intention-based models (such as the TPB and TAM model: attitude, self-efficacy and/or social support, perceived ease of use and perceived usefulness)?
4. Is the technical performance of the OEC sufficient for clinical use from the end user perspective?
5. Do patients’ interference of pain, actual pain levels, pain related fear of movement and general health change after six weeks of exercise follow-up treatment?
6. Do patients who used the OEC during their follow-up score better on interference of pain, actual pain levels, pain related fear of movement and general health than patients who did not use the OEC?
|- Timepoints||The main study parameter of this study is compliance with the exercise follow-up program. Patients are asked to fill out a weekly diary to log the frequency and duration of their exercise sessions and the type of exercises they performed. In addition compliance is logged by means entries of the Online Exercise Coach by the patient.|
1. Patients’ preferences towards exercise follow-up treatment - A preference elicitation questionnaire is used to investigate preferences for follow-up care. These are explicit measures of benefit valuation for assessing alternative health care interventions (Gerard et al, 2007). In this research we investigate so called ‘stated preferences’; individuals’ stated preferences in hypothetical (or virtual) markets;
2. Patients’ satisfaction with follow-up treatment - User satisfaction will be measured by means of a self-constructed questionnaire since no standardized and validated questionnaires are available to assess user satisfaction of teletreatment services like the Online Exercise Coach. The Theory of Planned Behaviour (TPB) (Ajzen, 1991) and the Technology Acceptance Model (TAM) (Davis, 1989; Davis, Bagozzi, & Warshaw, 1989), two models widely used and well-supported in the uptake of ICT based services, are used as underlying theoretical framework. The models suggest that behavioural intention is preceded by a patient’s perceived usefulness, perceived ease of use, attitude, social norm and self-efficacy. The items of the questionnaire will assess these determinants and their intention to use the OEC;
3. Effectiveness of follow-up treatment
Pain intensity (assessed by means of VAS scales)/ the level of subjectively experienced disability due to pain (assessed with the PDI, a self-rating scale that contains 7 items for the domains: A. family and home responsibilities, B. recreation - sports and leisure time activities, C. social activity - participation with friends and other acquaintances, D. occupation - activities partly or directly related to working, E. sexual behaviour – frequency and quality of sex life, F. self-care – basic life-supporting behaviours and G. daily activities)/ the level of pain-related anxiety (assessed with the PASS20, a scale that assesses self-reported levels of pain related anxiety) and hysical and mental health (assessed by the SF36 that measures eight domains of health);
4. Technical feasibility will be measured by means of automatic data logging of the Online Exercise Coach website. In addition, technical complaints of both patients and health care professionals will be registered and analysed. Therefore the professionals and patients are asked to log technical problems and failures they encounter and report this to the researcher by email or telephone;
5. Demographic characteristics.
|- Trial web site||www.r-motion.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc K. Cranen|
|- CONTACT for SCIENTIFIC QUERIES||MSc K. Cranen|
|- Sponsor/Initiator ||Roessingh Research and Development|
(Source(s) of Monetary or Material Support)
|Roessingh Research & Development|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||4-mrt-2009 - 14-sep-2009|